Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners A Randomized Clinical Trial
Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners A Randomized Clinical Trial
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DOI：
10.1001/jamanetworkopen.2019.1139
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发表时间：
2019-03-01
影响因子：
13.8
通讯作者：
Hunt, Timothy
中科院分区：
文献类型：
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作者：
El-Bassel, Nabila;Gilbert, Louisa;Hunt, Timothy
重要性 在美国，社区监督计划 (CSP) 中个体的艾滋病毒和性传播感染 (STI) 患病率高于一般人群。然而，迄今为止，尚未对 CSP 中的大量男性实施基于夫妇的 HIV 或 STI 预防干预措施。 目的 确定与 1 次咨询、检测和转诊 (CTR) 计划相比，5 次基于夫妇的预防干预措施在减少 CSP 中男性及其女性性伴侣之间的 HIV 和 STI 以及无安全套性行为方面的有效性。 设计、设置和参与者 进行了一项随机临床试验从2013年7月11日（第一次招募）到2016年5月17日（最后一次随机分组）。参与者是被委托接受 CSP 的涉毒男性及其女性性伴侣（n = 230 对夫妇或 460 人）。参与者是从纽约州纽约市的各个 CSP 站点招募的，并随机分为 PACT（保护和连接）干预条件或 HIV CTR 控制条件（n = 115 对夫妇或每组 230 人）。使用意向治疗方法对行为结果进行分析。统计分析于2017年11月1日至2018年6月1日进行。主要结果和措施使用过去90天内性行为的自我报告数据来评估所有时间点的行为结果。在基线和 12 个月时收集生物标志物，并在基线和 3、6 和 12 个月时收集行为结果。 结果 总共包括 230 对夫妇（460 人）。参与者的平均 (SD) 年龄为 35.0 (12.8) 岁，大多数参与者 (341 [74.1%]) 自我认定为黑人或非裔美国人种/民族。在 12 个月的评估中发现的 18 例新性传播感染病例中，10 例来自 PACT 组，8 例来自 HIV CTR 对照组。与对照组参与者相比，PACT 参与者与主要伴侣的无套阴道和/或肛交行为减少了 33%（发生率比 [IRR]，0.67；95% CI，0.45-0.99；P=.04），与其他伴侣的无套阴道和/或肛交行为减少了 70%（IRR，0.30；95% CI，0.12-0.74；P=.04）。在整个随访期间，与所有性伴侣的行为减少了 40%（IRR，0.60；95% CI，0.42-0.85；P=.005）。此外，PACT 参与者报告上次与研究伙伴进行阴道和/或肛交时受药物或酒精影响的可能性较小（比值比，0.55；95% CI，0.31-0.96；P=.04），并且在过去 90 天内性伴侣数量减少了 26%（IRR，0.74；95% CI，0.61-0.88；95% CI，0.61-0.88）。 P=.001）。 12 个月时，两组之间的 HIV 和 STI 发病率没有显着差异。 结论和相关性 PACT 干预似乎可以减少危险的性行为，例如无安全套性交；这一发现表明，以夫妇为基础的艾滋病毒和性传播感染预防干预计划可能会遏制艾滋病毒在 CSP 中迅速蔓延。
IMPORTANCE In the United States, the prevalence rates of HIV and sexually transmitted infections (STIs) are higher among individuals in community supervision programs (CSPs) than in the general population. However, to date, no couple-based HIV or STI prevention interventions have been implemented for the large number of men in CSPs.OBJECTIVE To determine the effectiveness of a 5-session couple-based prevention intervention, compared with a 1-session counseling, testing, and referral (CTR) program, in reducing HIV and STIs as well as condomless intercourse among men in CSPs and their female sexual partners.DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial was conducted from July 11, 2013 (first recruitment), through May 17, 2016 (last randomization). Participants were drug-involved men mandated to a CSP and their female sexual partners (n = 230 couples or 460 individuals). Participants were recruited from various CSP sites in New York, New York, and randomized into either the PACT (Protect and Connect) intervention condition or the HIV CTR control condition (n = 115 couples or 230 individuals in each arm). Analysis of behavioral outcomes used an intent-to-treat approach. Statistical analyses were conducted from November 1, 2017, through June 1, 2018.MAIN OUTCOMES AND MEASURES Self-reported data on sexual behaviors in the past 90 days were used to assess behavioral outcomes at all time points. Biomarkers were collected at baseline and 12 months, and behavioral outcomes were collected at baseline and 3, 6, and 12 months.RESULTS A total of 230 couples (460 individuals) were included. The mean (SD) age of participants was 35.0 (12.8) years, and most participants (341 [74.1%]) self-identified as black or African American race/ethnicity. Of the 18 new cases of STIs identified at the 12-month assessment, 10 came from the PACT arm and 8 from the HIV CTR control arm. Compared with the control participants, PACT participants had 33% fewer acts of condomless vaginal and/or anal intercourse with their main partner (incidence rate ratio [IRR], 0.67; 95% CI, 0.45-0.99; P=.04), 70% fewer acts with other partners (IRR, 0.30; 95% CI, 0.12-0.74; P=.009), and 40% fewer acts with all sexual partners (IRR, 0.60; 95% CI, 0.42-0.85; P=.005) over the entire follow-up period. In addition, PACT participants were less likely to report being under the influence of drugs or alcohol the last time they had vaginal and/or anal intercourse with their study partners (odds ratio, 0.55; 95% CI, 0.31-0.96; P=.04) and had 26% fewer sexual partners in the past 90 days (IRR, 0.74; 95% CI, 0.61-0.88; P=.001). At 12 months, HIV and STI incidence did not differ significantly between the 2 arms.CONCLUSIONS AND RELEVANCE The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests that a couple-based HIV and STI prevention intervention program may curb the burgeoning HIV epidemic in CSPs.